FDA Agrees to Forgo All Safety Trials for Pfizer’s New COVID Booster Shot This Fall
The COVID shots are a modern-day medical miracle. They’re safe, they’re effective, and they totally protect you from catching COVID unless you encounter one of those darned unvaccinated people. In which case you’ll catch COVID. Other than that, the shots are incredible.
So incredible that the FDA has just voted to waive clinical trials on the new Omicron-variant booster shots that Pfizer plans to release this coming fall. Pfizer is just that trustworthy!
You might feel some vaccine hesitancy over taking a newly invented booster shot this fall that hasn’t been through any safety trials AT ALL. But just relax and take the shot, otherwise the FDA will call you a conspiracy nut.
Pfizer plans to cobble together a new booster shot that combines elements of the original Wuhan coronavirus, elements of the Omicron variant, and two subvariants of Omicron called BA.4 and BA.5.
They took the plan to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This is a subcommittee that makes recommendations to the full FDA, and it has never made a recommendation that the FDA has not adopted.
In this case, VRBPAC voted 19 to 2 for Pfizer to go ahead and create what is effectively a brand-new shot for this fall’s booster. (This will be Shot #5 in the vaccine booster rollercoaster series for those keeping track on their COVID shot bingo cards at home.)
There are two things about this vote that are causing some doctors to worry. First, VRBPAC has never before in the history of its existence made a recommendation for a pharmaceutical company to modify a vaccine in order to target a variant. We’re in totally uncharted waters here with this decision.
Second, VRBPAC made no recommendation on whether new safety trials should be conducted on these altered booster shots. If the FDA approves VRBPAC’s recommendations (which they always do – it’s a rubberstamp process), there will not be any safety trials on these new booster shots. They’ll just be rushed out of the laboratory and into the arms of gullible people.
The logic behind this seems to be that since there were safety trials on the original shots, there’s no need for new trials because these new shots will have parts of the original shots’ ingredients.
Let’s try to break this down into plain English.
Pfizer is going to be allowed to create a brand-new shot based on a variant of a disease. And the FDA is not going to require any safety trials of this brand-new medicine, to see whether it has any harmful effects. This has never been done in the history of epidemiology before.
Can you imagine that happening for any other type of medicine? Whether it’s a new treatment for diabetes or a new pill for erectile dysfunction or a new type of allergy medicine, the medical process has always been slow and methodical previously. The reason for this is because in pre-FDA times, we used to just experiment and rush vaccines out – sometimes to harmful effect. We do it so that we don’t have any surprises later on, like “Whoops, sorry this medicine causes cancer five years after you take it!”
Speaking of which, did you know there haven’t been any cancer trials done on the original COVID shots yet? Not a single study has been conducted to determine whether COVID vaxed individuals have higher rates of cancer than the unvaccinated. We just don’t know the answer to that. And now the FDA is about to authorize the next booster shot with no trials at all.
Dr. Brian Hooker, the chief scientific officer and a professor of biology at Simpson University, says this about the FDA’s plans:
“The proposed move by VRBPAC will increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.”
Both Pfizer and Moderna have told the FDA that they can have their brand-new sub-variant experimental booster shots ready by October or early November. I’m no doctor, but can I go out on a limb and make a suggestion here?
Maybe… it’s not such a good idea to get one of these experimental shots, since the FDA is completely throwing safety trials out the window?